Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae
Randomised, Multicentre, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy and Pharmacodynamics After the Intravenous Administration of CAL02 in Severe Community-acquired Pneumonia Due to Streptococcus Pneumoniae
1 other identifier
interventional
19
2 countries
10
Brief Summary
The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2016
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedStudy Start
First participant enrolled
March 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2018
CompletedJanuary 27, 2020
January 1, 2020
1.9 years
October 19, 2015
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency, severity and characteristics of adverse events after two iv. administrations of CAL02.
To determine the safety profile of CAL02
29 days
Secondary Outcomes (4)
Clinical efficacy: cure.
29 days.
Pharmacodynamic effects.
29 days.
Microbiological efficacy.
29 days.
Survival.
29 days
Study Arms (3)
CAL02 Low-dose
ACTIVE COMPARATORLiposomal formulation
CAL02 High-dose
ACTIVE COMPARATORLiposomal formulation
Placebo
PLACEBO COMPARATORSaline
Interventions
Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion
Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion
Placebo administered administered 2 times (24 hours apart) as i.v. infusion
Eligibility Criteria
You may qualify if:
- Adult male or female patients ≥ 18 years and ≤ 80 years of age
- Body weight 40-140 kg
- Severe pneumonia caused by Streptococcus pneumoniae managed in an ICU
- CURB-65 score ≥ 3 in patients aged \> 65 and CURB-65 ≥ 2 in patients aged \< 65
- Streptococcus pneumoniae identification with the urine antigen test or any other proven documented identification method
- Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines
You may not qualify if:
- Patients with hospital-acquired-, health care-acquired- or ventilator- associated-pneumonia
- More than (i) 12 hours since diagnosis of severe CAPP and (ii) 24 hours or 60 hours since antibiotic treatment IV or per os, respectively, unless documented not to be active against S. pneumoniae, will have elapsed at the time of IMP administration
- APACHE II score \> 30 points
- SOFA score \> 12 points
- Inability to maintain a mean arterial pressure ≥ 50 mm Hg
- Known hypersensitivity to liposomal formulations
- Patients with severe neutropenia or lymphoma or current or anticipated chemotherapy
- End-stage neuromuscular disorders
- Patients who have long-term tracheostomy
- Current or recent participation in an investigational study
- Presence of other pneumococcal site infection
- Patients with known acquired immune deficiency syndrome (AIDS) with CD4 count \< 200 cells/mL
- Patients with known post-obstructive pneumonia (active primary lung cancer or another malignancy metastatic to the lungs)
- Patients with cystic fibrosis, Pneumocystis jiroveci pneumonia, or active tuberculosis
- Patients receiving immunosuppressant therapy
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Combioxin SAlead
Study Sites (10)
St Luc University Hospital
Brussels, Belgium
University Hospital Brussels
Brussels, Belgium
Clinique St Pierre
Ottignies, Belgium
CHU Jean Minjoz
Besançon, France
CHD Les Oudairies
La Roche-sur-Yon, France
Hôpital Mignot
Le Chesnay, France
CHU Dupuytren
Limoges, France
Centre Hospitalier Régional d'ORLEANS
Orléans, France
CH Yves Le Foll
Saint-Brieuc, France
CHRU de Tours
Tours, France
Related Publications (1)
Laterre PF, Colin G, Dequin PF, Dugernier T, Boulain T, Azeredo da Silveira S, Lajaunias F, Perez A, Francois B. CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: a first-in-human, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2019 Jun;19(6):620-630. doi: 10.1016/S1473-3099(18)30805-3. Epub 2019 May 2.
PMID: 31056427DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BRUNO FRANCOIS, MD
Centre Hospitalier Universitaire de Limoges CHU Dupuytren 2 Avenue Martin Luther King 87042 Limoges Cedex, France
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 22, 2015
Study Start
March 21, 2016
Primary Completion
February 20, 2018
Study Completion
February 20, 2018
Last Updated
January 27, 2020
Record last verified: 2020-01